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Frontotemporal DementiaPhase 2IEMONCT01937013

Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

A Phase 2 study testing Intranasal oxytocin and Saline Nasal Mist in people with Frontotemporal Dementia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls. Read more about this study

Who is it for?
Ages 30 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Frontotemporal Dementia
What is being tested?
Intranasal oxytocin and Saline Nasal Mist
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteCanada
Study dates
12 Sep 2013to 21 Dec 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients:
  • Ages 30-85
  • meet consensus criteria for probable behavioural variant FTD (bvFTD)
  • Controls:
  • Age and sex matched with patients
  • Mini-Mental State Exam (MMSE) scores >27

Who cannot join

  • Patients:
  • history of stroke
  • intracranial haemorrhage or other medical or neurological disorder apart from FTD that could affect cognition
  • diagnosis of bipolar disorder or schizophrenia not better accounted for by the diagnosis of FTD
  • cognitive impairment that precludes comprehension of task instructions
  • contraindication to MRI scanning
Show all 22Show fewer
  • severe language or memory deficits that preclude participation in the study visits and measures
  • females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause).
  • uncontrolled hypertension
  • bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm)
  • current use of prostaglandins
  • Controls:
  • history of stroke
  • intracranial haemorrhage or other medical or neurological disorder
  • diagnosis of bipolar disorder or schizophrenia
  • cognitive impairment that precludes comprehension of task instructions
  • contraindication to MRI scanning
  • severe language or memory deficits that preclude participation in the study visits and measures
  • females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause).
  • uncontrolled hypertension
  • bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm)
  • current use of prostaglandins

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Parkwood Hospital

    London, Ontario, N6C 5J1

Other trials in Canada

About this study

This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.

Read the detailed description

Frontotemporal dementia (FTD) and Pick's disease cause changes in personality, behaviour, and emotional responses. The usual treatments for Frontotemporal dementia focus on reducing agitation and aggressive behaviours. However, these drugs do not help all patients who experience blunting of emotion and loss of empathy. This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.

Being tested
Intranasal oxytocin, Saline Nasal Mist
Keywords
Frontotemporal Dementia, emotion, oxytocin, fMRI
Medical subject headings
Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intranasal oxytocinDrug

    Also called Syntocinon

    Oxytocin can be given intravenously (with a needle) or intranasally (a spray into the nose). The intravenous form of drug is approved by Health Canada for use in pregnancy. The intranasal formulation is not currently approved for use by Health Canada, but is used in Europe to induce labour in pregnant women or aid lactation (breastfeeding). Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3.

  • Saline Nasal MistDrug

    Also called Placebo

    Participants will be randomized to receive placebo on either study visit 2 or 3.

Study groups in NCT01937013
Study groupRoleWhat they receive
Intranasal OxytocinExperimentalParticipants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3
Receives: Drug: Intranasal oxytocin
Saline Nasal MistPlacebo comparatorParticipants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3
Receives: Drug: Saline Nasal Mist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional magnetic resonance imaging (fMRI) BOLD signal

    Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans

    Measured: 2 weeks

Secondary outcomes (1)

  1. Cognitive and Emotional Task performance

    Performance on standardized tasks of emotion processing and cognition

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2013 (estimated)
  2. Study start12 Sep 2013
  3. Primary completion21 Dec 2017
  4. Study completion21 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01937013
Sponsor's protocol ID
R-13-270
Other IDs
166786, 103555, FTDOXY13EF
Acronym
IEMO
Status last verified
Aug 2018
First submitted
3 Sep 2013
Last updated
8 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Oliver LD, Stewart C, Coleman K, Kryklywy JH, Bartha R, Mitchell DGV, Finger EC. Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study. Neurology. 2020 Nov 10;95(19):e2635-e2647. doi: 10.1212/WNL.0000000000010933. Epub 2020 Sep 22.

    PubMed 32963103

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intranasal oxytocin and Saline Nasal Mist in people with Frontotemporal Dementia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional magnetic resonance imaging (fMRI) BOLD signal (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01937013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.

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